Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial

PreDiabetes Clinical Trial

Official title:

Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06365723
• Other study ID #: SPH-2023-32410
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2025
• Est. completion date: June 15, 2032

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Sarah Rydell
• Email: rydel004[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Approximately 92 million U.S. adults (~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, we are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: June 15, 2032
• Est. primary completion date: June 15, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

Inclusion Criteria:

• 25-64 years old.
• Classified as overweight or obese with BMI 20.0-39.9 kg/m2.
• Documentation* of a PreD diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100- 125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of 5.7%-6.49%271; OR a study screening lab value of HbA1C within the aforementioned range.
• Currently engaged in =100 min/week of moderate to vigorous exercise
• confirmed via the Modifiable Activity Questionnaire.
• No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q) -this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status. Answering "yes" to any one of these questions may require a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention. The participant would not be enrolled until this doctor's note is received.
• Stable weight over the last 3 months (<10% change).
• Not currently pregnant, planning to become pregnant, or currently breastfeeding.
• Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
• Must own a smartphone and be willing and able to download the Garmin Connect app
• Ability to speak and understand English.
• Any level of income
• Any race/ethnicity

Exclusion Criteria:

• Individuals ,25 or >64: younger individuals may have not yet reached physiological maturity and in whom PreD prevalence is low; older individuals are more likely to have contraindications to PA and other comorbidities.
• BMI <20 or =40.
• Individuals with an HbA1c level <5.7% or >6.4%.
• Currently engaged in >100 min/wk of PA.
• Individuals with contraindications to exercise participation as indicated by the PAR-Q.
• A self-reported physical/mental disability that would prevent them from being able to adhere to the intervention.
• Past or current diagnosis of Diabetes (Type 1, 1.5 or 2) or use of diabetic medications (e.g. medications to control blood sugar)
• Any history of a cardiovascular disease event (e.g. heart attack, ablation, pacemaker, stroke) or taking medications to control arrhythmias
• Current treatment for cancer or heart disease (lipid and hypertensive medications acceptable but will be tracked closely).
• Any change within the last 3 months, or anticipated changes, of any medications that would affect study outcomes (e.g. medications for lipids, blood pressure, anxiety, depression)
• Current tobacco or nicotine users, or those who have quit within the last six months
• Excessive alcohol (on average>1 drinks/day for women &>2 drinks/day for men) or excessive recreational drug use (reported usage of once a week or more).
• Unstable weight over the last three months (>10% change).
• Those with major surgery planned or recent history of bariatric surgery (within last 2 years) or a history of other medical interventions that would interfere with
• Currently within one-year postpartum, currently pregnant, or planning to become pregnant during the study period.
• Currently breastfeeding.
• Unwilling to comply with study randomization procedures.
• Unwilling to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
• Current participation in another interventional clinical trial.
• Previous randomization in this study.

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Green Walk
All participants will be asked to walk three to five times per week for 30-50 minutes per walk, totaling 150 min/week, at moderate intensity over a 6-week period in a designated 'Green' urban environment.
• Gray Walk
All participants will be asked to walk three to five times per week for 30-50 minutes per walk, totaling 150 min/week, at moderate intensity over a 6-week period in a designated 'Gray' urban environment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Anxiety	An Ecological Momentary Assessment of anxiety (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk.	baseline and 6 weeks
Primary	Perceived stress assessment	Perceived stress will be measured using Cohen's Perceived Stress Scale 10 (PSS 10). An Ecological Momentary Assessment of stress (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk.	baseline and 6 weeks
Primary	Mood assessment	Mood will be evaluated with the validated 20-item Positive and Negative Affect Schedule. An Ecological Momentary Assessment of mood (rating level on a 0-10 point Likert scale) will be assessed pre/post each assessment walk.	baseline and 6 weeks
Secondary	Heart Rate variability	Heart rate variability (HRV) will be measured at the Baseline and Follow-up visits for each of the two study conditions (Weeks 1, 7, 12, and 18) as well as before, during, and after each of the four assessment walks. We will use the Zephyr BioHarness and associated BioModule to complete these measurements.	through study completion, up to 18 weeks
Secondary	Salivary cortisol levels	Saliva will be collected using the passive drool collection method at the following daily times: (1) immediately upon waking; (2) 30-45 minutes after waking; and (3) 14 hours after waking. Sampling times allow for calculation of the cortisol awakening response and diurnal decline in cortisol, metrics well correlated with health outcomes. Salivary cortisol will be assayed using validated ELISA assays	through study completion, up to 18 weeks
Secondary	Ambient Particulate Matter	Ambient Particulate Matter will be assessed using the AirBeam3, a palm-sized air quality instrument that measures PM1, PM2.5, PM10, temperature, and relative humidity. It will be worn during each of the four assessment walks, measuring air-quality in real time as the participant is out on their walk.	through study completion, up to 18 weeks
Secondary	Black Carbon levels	Black carbon will be assessed using the AirBeam3	through study completion, up to 18 weeks
Secondary	CMD risk	CMD risk score will be computed as the average of the z-scores comprised of systolic blood pressure, and fasting blood glucose, insulin, triglycerides, HDL-cholesterol (reverse scored), and waist circumference	through study completion, up to 18 weeks
Secondary	State and Trait anxiety	State and Trait anxiety will be assessed with the State-Trait Anxiety Inventory (STAI) at each of the pre/post clinical visits.	through study completion, up to 18 weeks